Associate Director, Statistical Programming

This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Associate Director of Statistical Programming will be responsible for statistical programming deliverables across Moderna’s development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients

Here’s What You’ll Do:

1. Oversee CRO’s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
2. Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs
3. Provide technical leadership in SAS programs and applications to report clinical trial data and for submissions of data in CDISC format
4. Generate SDTM domains, ADaM datasets, and define.xml files
5. Generate tables, figures, and listings as described in statistical analysis plans
6. Develop quality control processes for SAS programing and execute for regulatory reporting, publications, and press releases
7. Provide statistical programming support to exploratory analyses both internally and in response to regulatory agencies’ ad-hoc requests
8. Participate in the development of CRFs, edit check specifications, and data validation plans
9. Provide review and/or author data transfer specifications for external vendor data
10. Define and maintain data repository folder contents associated with statistical programming
11. Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices
12. Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc) to ensure meeting project timelines and goals
13. Oversee statistical programming contractors and mentor junior team members